Oral Nutrition Impact on Tear Film

Status unconfirmed · Phase 4

Conditions studied: Dry Eye Syndrome

In brief

Dry eye disease (DED) is a common but often inadequately treated disease of the tears and surface of the eye. It can cause poor vision and chronic pain and is more frequent with increasing age. The 1995 Report of the National Eye Institute/Industry Workshop on Clinical Trials in Dry Eye defined dry eye as "a disorder of the tear film due to tear deficiency or excessive evaporation, which causes damage to the interpalpebral ocular surface and is associated with symptoms of ocular discomfort". The International Dry Eye Work Shop (DEWS) committee subsequently defined dry eye as "a multi-factorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface." Typically, symptoms associated with dry eye disease include ocular burning, foreign body sensation (sand or grit), photophobia (light sensitivity), and other symptoms that result in overall long term discomfort in patients. The proposed eight week feasibility study if dry eye subjects confirmed elevated osmolarity and symptoms respond to nutritional therapy.

Key facts

Study ID

NCT01561040

Run by

Eye and Vision Technologies and Research Institute

People needed

80

Starts

2012-03-01

Expected to finish

2012-12-01

Last updated by the study team

2012-03-26

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18 to 79 at the time of informed consent.
• Must understand; be willing and able, and likely to fully comply with study procedures, visit schedule, and restrictions.
• A diagnosis of dry eye disease based on a global clinical assessment by the attending clinician, patient complaint of dry eye symptoms and osmolarity. There will be two osmolarity tiers; the lower tier is an open label design based on an average osmolarity between 316-326 mOsmo/L, and the other a group >=327 mOsmol/L. (Enrollment in the two tiers can either be simultaneous, or the second tier can be included after a responder analysis is done of tier 1).

You may not qualify if…

• Clinically significant eyelid deformity or eyelid movement disorder that is caused by conditions such as notch deformity, incomplete lid closure, entropion, ectropion, hordeola or chalazia.
• Previous ocular disease leaving sequelae or requiring current topical eye therapy other than for DED, including, but not limited to: active corneal or conjunctival infection of the eye and ocular surface scarring.
• Active ocular or nasal allergy.
• LASIK or PRK surgery that was performed within one year of Visit 1 or at any time during the study.
• Ophthalmologic drop use within 2 hours of any study visits.
• Pregnancy or lactation at any time during the study by history.
• Abnormality of nasolacrimal drainage (by history).
• Punctal cauterization or current punctal plug placement or within 30 days of punctual plug removal.
• Permissible Medications/Treatments- any commercially available OTC artificial tear.
• Prohibited Medications- Cyclosporine; any topical prescription medications (i.e., steroids, NSAIDs, etc); glaucoma medications; oral tetracyclines or topical macrolides; oral nutraceuticals (flax, fish, black currant seed oils, etc...) within 3 weeks of baseline.
• Started or changed the dose of chronic systemic medication known to affect tear production including, but not limited to antihistamines, antidepressants, diuretics, corticosteroids or immunomodulators within 30 days of Visit 1.

Where it is running

• Scot Morris — Conifer, Colorado, United States (enrolling)
• Davis EyeCare — Oak Lawn, Illinois, United States (enrolling)
• Koffler Vision Group — Lexington, Kentucky, United States (enrolling)
• Sean Mulqueeny OD — Creve Coeur, Missouri, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.